Method and apparatus for altering the charge distribution upon living membranes with functional stabilization of the membrane physical electrical integrity

ABSTRACT

A method and apparatus for altering the charge distribution upon living membranes with functional stabilizational of the membrane physical electrical integrity further comprising a method for using submicroscopic, quadripolar, circular, center charged, energy balanced magnetic device in a four (4) magnet array of alternating polarity in which the magnetic poles are separated only by a distance which will allow a magnetic sphere of influence on all adjacent poles to suppress the firing of action potentials of mammalian sensory neurons. The method and apparatus further provides a static magnetic device for production of a magnetic field for treatment of various disorders. Further there is provided a static magnetic device for production of a magnetic field for treatment of disorders wherein the device provides a static magnetic pole of like polarity on the outer surface of the flux focusing ring adjacent to each of the 4 poles of the invention (focusing magnet) such that the end r top of the focusing magnet is oriented to the geometric side of the pole such that the asix of the two magnets form a 45 to 90 degree angle.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This is a continuation-in-part of co-pending U.S. patentapplication Ser. No. 08/926,633, filed Sep. 10, 1997, incorporatedherein by reference, which application claims priority of U.S.Provisional Patent Application Serial No. 60/025,176, filed Sep. 10,1996. That provisional application is also incorporated herein byreference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0002] Not applicable

REFERENCE TO A “MICROFICHE APPENDIX”

[0003] Not applicable

BACKGROUND OF THE INVENTION

[0004] 1. Field of the Invention

[0005] The present invention relates to magnetic devices for therapeuticapplication to the human body, and more particularly to a static field,quadripolar magnetic treatment device with flux return means and afocusing means to increase the intensity, focus and gradient of thefield for placement against or in proximity to the human or other animalbody. The present invention further relates to methods of use andconstruction of such magnetic treatment devices for the treatment ofvarious animal diseases, complications and disorders such as, but notlimited to, a) acute and chronic pain, b) cardiac dysfunction, c)seizure disorders, d) pain and edema sustained in minor burns, insectbites and bee stings) potentiation of pharmaceuticals and focusing andfor concentrating the drug to the active site, f) protection oftransplant organs, g) treatment of movement disorders, h) control ofedema and pain as well as speed healing following surgical procedures,i) control of pain and sludging of sickled cells in sickle cell disease,j) foot pain and discomfort, k) Magna Scan device in the treatment ofpain and other dysfunctions, l) potentiation of epidural anesthesia andepidural analgesia, m) Protection from cell injury and death followingcell insults such as contusion, hypoxic stroke and infection, n) controlof nausea and vomiting associated with pregnancy, motion, andchemotherapy, o) prevention of fertilization of ovum by sperm, p)cumulative trauma disorder in the workplace, q) a magnetic placebo whichhas no biological activity yet is magnetic and has all characteristicsof the authentic device except the alternating poles and a significantfield gradient.

[0006] 2. General Background of the Invention

[0007] Magnetic fields have been applied to the human body for varioustherapeutic purposes for many centuries. For example, magnetic medicaltreatment devices for application against selected portions of the humanbody are disclosed in U.S. Pat. No. 3,921,620; method and apparatus forsuppressing neuron action potential firings U.S. Pat. No. 5,312,321;magnetic plasters for improving circulation are disclosed in U.S. Pat.No. 4,489,711; magnetic fields for stimulation of bone growth aredisclosed in U.S. Pat. No. 4,105,017; and magnetic stimulation of nervecells has been accomplished with devices such as the CadwellMagneto-Electric Stimulator (MES-10) manufactured by CadwellLaboratories, Inc. Of Kennewick, Wash.

[0008] Various disease states, tissue and organ malfunction may be theresult of loss of membrane stability and normal permeability. Thesemembranes may be cellular of intracellular, but in any case representmalfunction of excitable tissue. This malfunction of excitable tissuemay be due to alteration of ion channel function. These various diseaseand states of malfunction may also be related to alteration of receptorsites or agonist sites of enzymes and/or other such dynamic systemswithin living organisms and more particularly the human animal. A greatvariety of symptoms and malfunctions may occur, such as, but not limitedto, the above listed disease and/or disorder states.

[0009] Unfortunately, many types of ailments, including chronic pain,poor localized blood flow, cerebral edema and certain seizures andinjuries cannot be successfully treated with conventional drug, physicaltherapy or surgical therapies. Because such ailments are oftenuntreatable with conventional therapies, there is a need for alternativetherapies that relieve these previously untreatable or poorly treatableconditions.

[0010] U.S. Pat. Nos. 5,312,321 (issued May 17, 1994) and 5,941,902(issued Aug. 24, 1999) are also incorporated herein by reference.

BRIEF SUMMARY OF THE INVENTION

[0011] The apparatus of the present invention solves the problemsconfronted in the art in a simple and straightforward manner. What isprovided is a therapeutic static magnetic treatment device adapted forplacement of at least four magnetic flux generator poles is applied suchthat they may be applied to the animal or human body as described forthe various applications revealed herein. The device comprises aplurality of static magnetic bodies in each head of the applications,having at least two positive and two negative magnetic polessubstantially in a single plane, the magnetic poles being oriented todefine the four vertices of a quadrilateral shape, the two positivepoles defining opposite diagonal vertices, and the two negative polesdefining opposite diagonal vertices of the quadrilateral shape, each ofthe magnetic poles being magnetically attracted by the oppositelycharged poles and being magnetically repelled by the like charged poles.

[0012] An object of the invention is to provide a static magnetic devicefor production of a magnetic field for treatment of pain disorders, sucha device being powered by a particular static magnetic field and having,inter alia, an alternating polarity, quadripolar array which generates a3 dimensional, steep field gradient (greater than 0.25 mt/mm) with ahomogenous field.

[0013] It is a further object of this invention to provide analternating, quadripolar array in which each of the poles is in theshape of two cones joined at the directrix of the cone with the vertexof the two cones lying in a perpendicular axis of a circular directrix.

[0014] Furthermore, there is taught a method and apparatus for alteringthe charge distribution upon living membranes with functionalstabilization of the membrane physical electrical integrity.

[0015] An object of this invention to provide a device that alters thestability of excitable membranes and other charged structures andsystems in order to treat ailments in animals.

[0016] Another object of this invention is to present a global techniquefor controlling the physical and electrical stability of irritablemembranes (either cell walls or intra5 cellular organelles) and alteringreceptor sites, i.e. enzymes, hormones and/or drugs.

[0017] There is further taught a device in which the desired biologicaleffects are directly related to the magnitude of the gradient in the x,y and z axis and therefore the magnitude of the vector or summationgradient.

[0018] In the Detailed Description an array of containment means,support means, energizing means and control means of the embodimentswill be presented for a variety of therapeutic purposes along withsupport data for the application.

[0019] The accompanying drawings, which are incorporated herein andconstitute a part of this specification, illustrate presently preferredembodiments of the invention, and together with the description, serveto explain the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Device

[0021]FIG. 1 is a perspective view of an embodiment of a magnetic devicein accordance with the principles of the invention.

[0022]FIG. 2 is a cross section of the magnetic device in FIG. 1 alongthe line 2-2.

[0023]FIG. 3 is a plan view of the magnetic device in FIG. 1.

[0024]FIG. 4 is an exploded diagram of the magnetic device in FIG. 1.

[0025]FIG. 5 is a side view of a “coned” magnet from the magnetic devicein FIG. 1. Also included is a “single coned” magnet.

[0026] FIGS. 6A-6B are illustrations of the magnetic field of magneticdevice of FIG. 1, and another illustration of that device respectively.

[0027] FIGS. 7A-7B are illustrations of the magnetic field of anothermagnetic device (with only two “coned” magnets) and an illustration ofthat device respectively.

[0028]FIG. 8 shows oscilloscope traces from texts on mammalian nervecells conducted using the magnetic device of FIG. 1.

[0029]FIG. 9 is a graph comparing the average number of times neuronsfailed to elicit action potentials in response to applied stimulibefore, during and after exposure to the magnetic device of FIG. 1 andto similar magnetic devices in which the magnets were spaced from eachother at various distances.

[0030]FIG. 10 is a bar graph representing the magnetic energy in milliTesla (mT) as measured over the center of the pole in each of the 4poles of a device as in FIG. 1 soon after it was manufactured in 1993.

[0031]FIG. 11 is a bar graph representing the magnetic energy in milliTesla (mT) as measured over the center of the pole in each of the 4poles of a device as in FIG. 1 in 1993, the device being manufactured in1989.

[0032]FIG. 12 is a bar graph representing the magnetic energy in milliTesla (mT) as measure in clockwise fashion over each pole of a device inFIG. 1 which was manufactured in 1989 and 1993—measurement was done in1993.

[0033]FIG. 13 is a graph comparing the average number of times neuronsfailed to elicit action potentials in response to applied stimuli duringexposure to the magnetic device of FIG. 1 for devices manufactured in1989 (50% loss of energy in one pole) and 1993 (full energy in each of 4poles).

[0034] A. Pain and Swelling

[0035]FIG. 14 is a view of a treatment application to the human body forrelated pain and smelling applications.

[0036] B. Pain and Edema Sustained in Minor Bums, Insect Bites and BeeStings

[0037]FIG. 15 Human Figure with “Band Aide”—Round and rectangular

[0038] C. Foot Pain and Discomfort

[0039]FIG. 16 is a side cross-sectional view of a shoe according to oneembodiment of the invention.

[0040]FIG. 17 is a top cross-sectional view of the sole of the shoe ofFIG. 1.

[0041] E. Control of Edema, Pain and Swelling as well as Speed HealingFollowing Surgical Procedures

[0042]FIG. 18 Placement over surgical incision on human

[0043]FIG. 19 Graft of healing and Edema vs control

[0044] F. Potentiation of Epidural Anesthesia and Epidural Analgesia

[0045]FIG. 20 is a side view of an experimental design used to monitorthe suppression of nerve cell action potentials with the method of thepresent invention.

[0046]FIG. 21 is a plan view of the epidural catheter that may be usedin applying the method of the intervention.

[0047]FIG. 22 is a cross-sectional view through a thoracic vertebrae,showing placement of the epidural catheter.

[0048]FIG. 23 is a perspective view of an embodiment of a magneticdevice without “cones” in accordance with the principles of theinvention.

[0049]FIG. 24 is a cross section of the magnetic device in FIG. 23 alongthe line III-III.

[0050]FIG. 25 is a plan view of the magnetic device in FIG. 23.

[0051]FIG. 26 is a side view of a magnet (without cones) from themagnetic device in FIG. 23.

[0052]FIG. 27 is a top view of the magnetic device of FIG. 23, with dotsadded to designate surface magnetic field measurement locations.

[0053]FIG. 29 is a graph of magnetic field measurements taken at themeasurement locations designated in FIG. 27.

[0054] FIGS. 30-36 are grids of magnetic field measurements taken atvarious distances from the surface of the magnetic device of FIG. 23.

[0055]FIG. 37 is a magnetic field plot for the magnetic device of FIG.23.

[0056]FIG. 38 is a magnetic field plot for a magnetic device having onepositive and one negative magnetic pole.

[0057] FIGS. 39-43 are a series of diagrams showing the output on anoscilloscope connected to an electric probe inserted in a mammaliannerve cell. 3

[0058]FIG. 44 is a graph showing average number of times neurons failedto elicit action potentials in response to stimuli applied as describedin Example No. 9.

[0059]FIG. 45 is a photographic series showing the output on anoscilloscope connected to an electric probe inserted in a mammalianC-fiber in tissue culture; both before, during and after exposure to themagnetic field generated by the epidural Magna Cath™. This recordingclearly shows that the Magna Cath™ reversibly blocks C-fiber firing invitro.

[0060]FIG. 45A demonstrates that the Magna Cath™ doesn't alter theelectronics.

[0061]FIG. 45B demonstrates that the Magna Cath™ significantly altersthe action potential latency of C-fibers when quantitatively compared tocontrol before and after treatment.

[0062]FIG. 45C demonstrates the prolonged action potential duration ofC-fibers when exposed to the Magna Cath™.

[0063]FIG. 45D depicts dramatic failure of action potentials on aquantitative basis when stimulated at 1 Hz and exposed to the MagnaCath™.

[0064]FIG. 45E reveals a significant change in the dv/dt when C-fibersare exposed to the Magna Cath™. This change is related to change insodium currents.

[0065]FIG. 45F represents the time required to block and for recovery ofC-fiber action potential.

[0066]FIG. 46 illustrates a magnetic field around devices and comparisonfailures between Magna Bloc™ and a 16 array of magnets.

[0067]FIG. 47 shows the arrangement of two magnetic devices and themeasurement of their magnetic field.

[0068]FIG. 48 is a graph showing the magnetic field for devices of FIG.47.

[0069]FIG. 49 illustrates the field around the device and a two magnetdevice, and shows comparative neurons firing data for the two devices.

[0070]FIG. 50 schematically illustrates the apparatus used to measurethe magnetic field data in FIGS. 47 and 48.

[0071]FIG. 51 is a graph comparing the average number of times neuronsfailed to elicit action potentials in response to applied stimulibefore, during and after exposure to the magnetic device of FIG. 23 andto similar magnetic devices in which the magnets were spaced from eachother at various distances.

[0072]FIG. 52 shows a test fixture in which the magnets were held duringthe testing for which the data are shown in FIG. 51.

[0073] FIGS. 53-56 are illustrations and graphs demonstrating thedifference in pole strengths and a comparison of their effectiveness onblocking C-fibers.

[0074] G. Cardiac Dysfunction

[0075]FIG. 57 Human Figure with Cardiac application

[0076]FIG. 58 Figure with internal implantable

[0077] H. Control of Pain and Sludging of Sickled Cells in Sickle CellDisease

[0078]FIG. 59 Placement of Human Body

[0079] I. Seizure Disorders

[0080]FIG. 60 Human External application

[0081]FIG. 61 Human Implantables

[0082] J. Treatment of Movement Disorders

[0083]FIG. 62 Attachment to the head

[0084]FIG. 62 Implant near the basal ganglia

[0085] K. Protection of Transplant Organs

[0086]FIG. 63 Transport Box

[0087]FIG. 64 Photomicrograph of heart, liver and kidney

[0088] a b c

[0089] N. MagnaScan™ Device for Locating and Confirming the Placement ofthe Quadripolar Magnet Device in the Treatment of Pain and OtherDysfunctions

[0090]FIG. 65 Device—Side view according to one embodiment of theinvention.

[0091]FIG. 66 Rear view showing controls and liquid crystal display.

[0092]FIG. 67 Front view of the scan device showing the 2 turrentmounted annub electrodes.

[0093]FIG. 68 Schematic representation of anatomical connectionsassociated with pain perception.

[0094]FIG. 69 Relationship of current density to control of peripheralC-fiber firing as measured by the area of hyperalgesia followingintradermal capsaicin injection.

[0095]FIG. 70 time and current density relationships on the evolution ofhyperesthesia and hyperalgesia, following intradermal capsaicininjection.

[0096]FIG. 71 Relationship of current density, time and magnetic fieldof the invention to the evolution of hyperesthesia and hyperalgesia,following intradermal capsaicin injection.

[0097]FIG. 72 Relationship of current density, time and magnetic fieldof the invention to evolution of hyperesthesia and hyperalgesia,following intradermal capsaicin injection.

[0098]FIG. 73 Same as 1.6 FIG. 72.

[0099]FIG. 74 Same as 1.6 FIG. 72.

[0100]FIG. 75 Same as 1.6 FIG. 72.

[0101]FIG. 76 Relationship of time in both quadripolar alternating fieldmagnetic device of the invention and magnetic placebo to evolution ofhyperalgesia after injection of capsaicin in the forearm.

[0102] O. Potentiation of Pharmaceuticals for Focusing and forConcentrating the Drug to the Active Site

[0103]FIG. 77 Embodiment on Human Body—Potentiation of Lidocaine

[0104]FIG. 78 Isolated Cell ______ Lidocaine

[0105]FIG. 79 Capsaicin Ca block

[0106]FIG. 80 Shifting of Dose response curve of Dilantin

DETAILED DESCRIPTION

[0107] Device

[0108] This invention provides a device with four magnetic poles ofalternating polarity in which the shape of the poles is in the form oftwo cones joined at the directrix with the vertex of the two cones lyingin a perpendicular axis of a circular directrix of the cones such thatthe vertex of the cone shaped magnetic bodies may all be tilted toward(or away from) the midline (on the side facing the animal body) suchthat the peak or vertex migration toward the midline will vary (orsharpen the angle of) the field gradient.

[0109] There is further taught the method which provides a device withfour magnetic poles of alternating polarity in which the shape of thepoles are in the form of a single cone with the vertex of the conefacing the body of the animal and the directrix of the cone attached tothe flux return ring and facing away from the animal body. The vertexmay be tilted toward the midline (on the side facing the animal body)such that the peak or vertex migration toward the midline will alter thefield gradient.

[0110] It is a further object of this invention to provide a devicewhich contains a flux return ring on the back surface away from the bodysurface which is designed to return the magnetic flux thereby altering(increasing) the strength and gradient without materially altering thecenter charge symmetry and homogeneity of the 3 dimensional steepgradient field.

[0111] Another object of the invention is to provide a flux focusingring surrounding the 4 (static) magnetic poles on the outer perimeterstationed substantially midway between the top and bottom of the pole.Attachment means is provided to hold the focusing ring to the outerperimeter of the poles throughout the total support means.

[0112] It is a further object of the invention to provide a staticmagnetic pole of like polarity on the outer surface of each of the 4poles of the invention (focusing magnet) such that the top of thefocusing magnet is oriented to the geometric side of the pole such thatthe axis of the two magnets form a 45 to 90 degree angle or a 90° to135° angle. The focusing magnet comprises a static magnetic pole.

[0113] It is a further object of the invention to provide a staticmagnetic pole of like polarity on the outer surface of the flux focusingring adjacent to each of the 4 poles of the invention (focusing magnet)such that the end or top of the focusing magnet is oriented to thegeometric side of the pole such that the axis of the two magnets form a45 to 90 degree angle. The focusing magnet comprises a static magneticpole. The angle of the focusing magnet is such that the axis forms a 45to 90 degree angle on the body surface side and a 90 to 135 degree tothe surface away from the body.

[0114] It is a further object of the invention to control the focusingof each magnet with a smaller and weaker magnet than the primary polesuch that the focusing ring containing magnets can focus and balance thesymmetry of the therapeutic field

[0115] A further object of this invention is to reveal a method ofdesign and manufacture of an inexpensive, center charged and homogeneousstatic magnetic flux magnet.

[0116] Preferably; the plurality of magnet bodies in each devicecomprises four substantially identical static magnets, the staticmagnetic poles are the shape of a cylinder or preferably in the shape oftwo cones joined at the directrix of the cone with the vertex of the twocones lying in a perpendicular axis of the circular directrix such thatthe vertex of the double cone shaped magnetic bodies may all be tiltedtoward the midline (on the side facing the animal body) such that thepeak or vertex being pulled toward the midline will give a more steepfield gradient.

[0117] It is further preferred that the device contains a flux returnring on the back surface away from the body surface which is designed toreturn the magnetic flux thereby increasing the strength and gradientwithout altering the center charge symmetry and homogeneity of the 3dimensional steep gradient field.

[0118] It is further preferred that a flux focusing ring surrounds the 4static magnetic poles on the outer perimeter stationed midway betweenthe top and bottom of the pole at the junction of the base of the twocone shapes which join at the directrix of the cone.

[0119] On the outer surface of each of the 4 poles of the inventionattached to the flux focusing ring is a small focusing cylindricalmagnet oriented to the geometric side of the pole such that the axis ofthe two magnets from a 45 to 90 degree angle (Focusing magnet/Magnetpole=¼ in size). It is further preferred that the containment means beplastic which covers the entire embodiment. The size of the device isdictated by the application, but averages about 1″×¼″ inches in theround.

[0120] It is a further object of the invention to present a method ofadding a plastic material to a permanent magnet amalgam along with aproprietary silica colloid and curing the amalgam under the influence ofa strong, center charged homogenous magnetic field.

[0121] Pain Applications

[0122] A. Pain and Swelling and Wound Healing

[0123] 1. Acute Pain and Edema

[0124] It is a further object of the invention to provide a device thatalters nerve cell behavior in a manner that reduces painful sensations.

[0125] Another object of the invention is to provide an apparatus forapplying a symmetric quadripolar, three dimensional magnetic flux fieldwhich is focused and balanced to the human body to stabilize excitablemembranes and thereby reduce pain and edema associated with acuteinjury, inflammation or surgical procedure and to decrease wound healingtime.

[0126] Another object of the invention is to provide a specializedmagnetic flux field to control and reverse the swelling associated withacute injury, inflammation and surgery.

[0127] A further object of the invention is to provide a method forapplying a therapeutic magnetic device to the human body to relievepain, improve blood flow, decrease healing time, and reduce swellingassociated with injury, surgery or acute inflammation.

[0128] 2. Chronic Pain

[0129] It is a further object of the invention to provide a device thatalters nerve cell behavior in cases of chronic pain to block thespontaneous pacemaker firing of the chronically malfunctioning painfiber (mostly A-fibers and C-fibers).

[0130] Another object of the invention is to provide an apparatus forapplying a symmetric, quadripolar, three dimensional magnetic flux fieldwhich is focused and balanced to the human body to stabilize excitablemembranes and thereby reduce pain associated with the spontaneouspacemaker firing of chronically malfunctioning polymodal nociceptors(afferent C-fibers and A8 fibers).

[0131] Another object of the invention is to provide a specializedmagnetic flux field to control and speed healing of chronic non-healingwounds.

[0132] In accordance with the principles of the present invention asembodied and as broadly described herein, a therapeutic static magnetictreatment device adapted for placement against the bodies of livinganimals is provided. The device comprises a plurality of static magneticbodies having at least two positive and two negative magnetic polessubstantially in a single plane, the magnetic poles being oriented todefine the four vertices of a quadrilateral shape, the two positivepoles defining opposite diagonal vertices and the two negative polesdefining opposite diagonal vertices of the quadrilateral shape. Each ofthe magnetic poles being magnetically attracted by the two oppositelycharged poles and being magnetically repelled by the like charged poles.

[0133] B. Pain and Edema Sustained in Minor Bums Insect Bites, BeeStings and Minor Cuts and Abrasions.

[0134] The present invention relates to magnetic devices for therapeuticapplication to the human body, and more particularly to a smalldisposable, multiple quadripolar treatment device contained in a smallsterile disposable bandage for placement on the human body for controlof pain and edema sustained in minor bums, insect bites, bee stings andminor cuts and abrasions.

[0135] Preferably, the invention will provide a magnetic device thatalters the permeability of the ion channels in membranes to the flow ofsodium and calcium and thereby stabilizes the spontaneous firing ofdamaged nerve endings as well as restores the physical integrity of themembranes and thereby stops the abnormal loss of cellular fluid (edema).

[0136] Minor bums, insect bites, bee stings and minor cuts and abrasionsare the most common injuries in our society, yet they are among the mostpainful and annoying injuries in our society. The only treatment formass use is cleansing, antibiotic ointment and clean bandage.

[0137] There is a great need for a bandage which will provide a sterilecover for such wounds as well as to acutely control pain, swelling andto promote healing.

[0138] Accordingly, it is an object of the invention to provide a devicethat is small enough to be contained in a small sterile bandage“Band-Aid” inexpensive enough to be disposable and that alters painfiber firing, repairs membrane integrity, controls edema in the area ofthe injury and promotes healing.

[0139] Another object of the invention is to provide a magnetic devicethat alters the permeability of the ion channels in membranes to theflow of sodium and calcium and thereby stabilizes the spontaneous firingof damaged nerve endings as well as restores the physical integrity ofthe membranes and thereby stops the abnormal loss of fluid by cells.

[0140] C. Foot Pain and Discomfort.

[0141] Another object of the invention is to present an embodiment ofthe present invention which relates to magnetic devices for therapeuticapplication to the human body, and more particularly to a quadripolarstatic magnetic device adapted for the utilization in the soles of shoesemploying a new and very economic method of manufacturing and applyingthe magnet of the invention to the soles of shoes.

[0142] The present invention relates to magnetic devices for therapeuticapplication to the human body, and more particularly to a quadripolarstatic magnetic device with gradient focusing means for utilization inthe soles of shoes.

[0143] Pain sensations in the human body can be a result of impropernerve function, as when such pain or discomfit is caused by inordinatelyexcitable nerve cells or by nerve cells having leaky cell wallmembranes. Pain sensations may also be caused by damaged or contusednerve cells. Even when nerves function properly, fatigue and painsensations are initiated through nerve cells which are irritated byfatigued tissue. Thus, relief from foot pain and fatigue should beobtainable by altering nerve cell function, as for example bystabilizing nerve cell wall membrane.

[0144] Unfortunately, many types of foot fatigue and pain cannot besuccessfully treated with conventional drug or physical therapies.Because foot fatigue and pain induced by standing, walking or runningare often untreatable with conventional therapies, there is a need foralternative therapies that relieve these symptoms by altering nervefunction and blood circulation in the feet. Accordingly, it is an objectof the invention to provide a magnetic device and method for applyingthe device against the human foot so as to alter nerve behavior in amanner that reduces foot fatigue and pain. It is a further object of theinvention to provide a magnetic device and a method for applying thedevice against the human foot so as to improve blood circulation.

[0145] It is preferred that the containment means for the invention bemade of a flexible material so that placement in a shoe sole will notrestrict flexibility.

[0146] In accordance with the invention, at least one therapeuticpermanent magnet device is embedded in a shoe. Preferably, one permanentmagnet device is embedded in the heel of the shoe's sole while a seconddevice is embedded in the portion of the shoe's sole corresponding tothe ball of the foot. The shoe into which the magnetic treatment devicesare embedded may be of any type of footwear, as for example, runningshoes, nurses shoes or work boots.

[0147] It is further preferred that the device be at a low enough costto make placement in a shoe economically feasible. It is thereforedesired that the best product be produced for the lowest price.Therefore, a method will be revealed for forming the magnetic nucleus ofthe device in one simple molding process and the device will then beplaced in a vulcanized rubber embodiment for placement in the shoe.

[0148] D. Cumulative Trauma Disorder.

[0149] It is a further object of the invention to provide a device thatalters nerve cell behavior in cases of chronic pain to block thespontaneous pacemaker firing of the chronically inflamed, edematous,malfunctioning pain fibers in chronic trauma disorders such as CarpelTunnel Syndrome.

[0150] Another object of the invention is to provide an apparatus forapplying a symmetric, quadripolar, three dimensional magnetic flux fieldwhich is focused and balanced to the human body to stabilize excitablemembranes and thereby reduce pain associated with the spontaneouspacemaker firing of chronically traumatized and malfunctioning polymodalnociceptors.

[0151] Another object of the invention is to provide a specializedmagnetic flux field to remove edema and control pain in a chronicallytraumatized tissue.

[0152] It will be apparent to those skilled in the art that theapparatus of this invention alters C-filters firing both in vitro and invino.

[0153] Additionally, the invention provides a static magnetic pole oflike polarity on the outer surface of each of the 4 poles of theinvention (focusing magnet) such that the top of the focusing magnet isoriented to the geometric side of the pole such that the axis of the twomagnets form a 90° to 135° angle. The focusing magnet comprises a staticmagnetic pole.

[0154] This application further reveals a method and technique forplacement of the devices over areas of chronic trauma such that theywill alter nerve cell behavior in cases of chronic pain to block thespontaneous pacemaker firing of the chronically traumatized, enflamed,edematous, malfunctioning, pain fiber in chronic trauma disorders suchas Carpel Tunnel Syndrome.

[0155] Additional objects and advantages of the present invention willbe set forth in part in the description that follows and, in part, willbe from the description or may be learned by practice of the invention.

[0156] E. Control of Edema and Pain as well as Speed Healing FollowingSurgical Procedures and Speed Healing Rates of Chronic Non-HealingWounds.

[0157] This application further reveals a method and technique forplacement of the invention on post operative incisional sites for thebenefit of pain control, edema control and increased healing rates.

[0158] There is taught a device providing an apparatus for applying asymmetric quadripolar, three dimensional magnetic flux field which isfocused and balanced to the human body to stabilize excitable membranesand thereby reduce pain and edema associated with acute injury,inflammation or surgical procedure and to decrease wound healing time aswell as speed healing of tissue following surgical procedures and speedhealing rates of non-healing wounds.

[0159] There is further taught the method which provides for applying atherapeutic magnetic device to the human body to relieve pain, improveblood flow, decrease healing time, and reduce swelling associated withinjury, surgery or acute inflammation along with reducing or blockingswelling and speed healing following surgical procedures.

[0160] There is further provided the device which provides a specializedmagnetic flux field to control and speed healing of chronic non-healingwounds.

[0161] There is further taught the methods, devices, techniques, andprocesses which relate specifically to control of edema and pain as wellas speed healing following surgical procedures and speed healing ratesof chronic non-healing wounds.

[0162] There is further taught the method which provides a device thatalters cell behavior in a manner that reduces pain, swelling and speedshealing following operative procedures and of non-healing wounds andspeeds healing.

[0163] 1. Post Operative Treatment

[0164] It is a further object of this invention to provide a device thatalters cell behavior in a manner that reduces pain, swelling and speedshealing following operative procedures.

[0165] There is further taught the device which provides a specializedmagnetic flux field to control and reverse the swelling associated withacute injury, inflammation and surgery.

[0166] Another object of the invention is to provide an apparatus forapplying a symmetric quadripolar, three dimensional magnetic flux fieldwhich is focused and balanced to the human body to stabilize excitablemembranes and thereby reduce pain and edema as well as speed healing oftissue following surgical procedures.

[0167] A further object of the invention is to provide a method forapplying a therapeutic magnetic device to the human body to relievepain, improve blood flow, reduce or block swelling and speed healingfollowing surgical procedures.

[0168] 2. Chronic Non-Healing Wounds

[0169] It is a further object of this invention to provide a device thatalters cell behavior in a manner that reduces pain, swelling and speedshealing of non-healing wounds.

[0170] Another object of the invention is to provide an apparatus forapplying a symmetric quadripolar, three dimensional magnetic flux fieldwhich is focused and balanced to the human body to stabilize excitablemembranes, improve blood flow, relieve pain, reduce swelling and speedhealing rates of non-healing wounds.

[0171] It is a further object of the invention to present an applicationof the quadripolar array in a microscopic embodiment which is housed ina catheter designed to be placed in the epidural space and other bodycavities such that the magnetic quadripolar flux generators are arrangedin a helix such that migration or rotation of the device will not alterthe efficacy of the therapeutic device.

[0172] F. Potentiation of Epidural Anesthesia and Epidural Analgesia.

[0173] There is taught the embodiment of implantable quadripolar deviceswhich contain flux focusing and flux return rings.

[0174] There is further taught the application of the quadripolar arrayin a microscopic embodiment which is housed in a catheter designed to beplaced in the epidural space and other body cavities such that themagnetic quadripolar flux generators are arranged in a helix such thatmigration or rotation of the device will not alter the efficacy of thetherapeutic device.

[0175] There is further taught the methods, devices, techniques, andprocesses which relate specifically to potentiation of epiduralanesthesia and epidural analgesia.

[0176] There is further taught he methods, devices, techniques, andprocesses which specifically relates to a method for usingsubmicroscopic, quadripolar, circular, center charged, energy balancedmagnetic device in a four (4) magnet array of alternating polarity inwhich the magnetic poles are separated only by a distance which willallow a magnetic sphere of influence on all adjacent poles to suppressthe firing of action potentials of mammalian sensory neurons.

[0177] There is further taught the method which provides for applying amagnetic field which is particular to this device, to a nerve cell suchthat it alters nerve behavior.

[0178] There is further taught the method which provides applying themagnetic field to the dorsal root ganglia by placing the device in theepidural space adjacent to the dorsal root.

[0179] There is further taught the method which provides for a catheterto modulate or suppress C-fiber firing.

[0180] There is further taught the method which provides for the helicaldesign of the catheter so as to allow impingement of the dorsal rootregardless of the catheter's rotation.

[0181] There is further taught the method which provides for a magneticdevice with a configuration of static magnets with a particular poledesign that, when placed close to a nerve cell, alters the nerve cell'sresponses to external electrical stimuli.

[0182] In accordance with the principles of the present invention asembodied and as broadly described herein, a method for suppressing nervecell (particularly C-fiber) action potentials is provided. According tothe invention, a magnetic treatment device is placed at such a distancefrom a mammalian sensory neuron that the magnetic field of the treatmentdevice reaches the sensory neuron. During such placement, and for aperiod thereafter, the nerve cell action potentials are suppressed.

[0183] The magnetic treatment devices is comprised of four magneticbodies having two positive and two negative magnetic poles substantiallyin a single plane, the magnet poles being oriented to define the fourvertices of a quadrilateral shape, the two positive poles definingopposite diagonal vertices, and the two negative poles defining oppositediagonal vertices of the quadrilateral shape. Containment means areprovided for holding the magnetic poles of the magnetic bodies in thequadrilateral orientation in the catheter by embedding thesubmicroscopic magnet devices in the wall of the catheter. The pluralityof magnet bodies comprises four substantially identical cylindricalmagnetic bodies, each having one magnetic center charge face. It isnecessary that two of the cylindrical magnetic bodies have a positivemagnetic pole on one face and two of the magnetic bodies have a negativemagnetic pole on one face, and that the two positive and two negativemagnetic poles on the magnetically charged faces of the four magnetbodies be in the quadrilateral orientation described above. Theproximity of the individual magnets within the device must bemaintained. Separation of the individual magnets or bringing the devicein close proximity to other magnets will cause interference with themagnetic field and will change the flux lines and gradient of the fieldso that the device will not effectively alter the C-fiber firing.

[0184] The present invention relates to a method for usingsubmicroscopic, quadripolar, circular, center charged, energy balancedmagnetic devised in a four (4) magnet array of alternating polarity inwhich the magnetic poles are separated only by a distance which willallow a magnetic sphere of influence on all adjacent poles to suppressthe firing of action potentials of mammalian sensory neurons. Thesesubmicroscopic magnetic arrays are placed in an epidural catheter. Theyare placed in a helical arrat with the distance between magneticclusters being 1 cm (a distance which breaks the sphere of influence,one cluster field to another). The cluster are rotated about 43° insuccession one cluster to the next. There is a difference in electricalpotential across a cell membrane of sensory neurons. When a neuronreceives an impulse transmitted from another nerve cell, the electricalpotential difference across the membrane of the cell is dramaticallyreduced and generally reverses. This reduction and reversal of potentialis referred to as the firing of the neurons action potential. If suchaction potential firings are suppressed, the transmissions of nerveimpulses are also suppressed.

[0185] Pain sensations in the human body can be a result of impropernerve function, as when such pain is caused by inordinately excitablenerve cells or by nerve cells having cell wall membranes that leak ions.Pain sensations may also be caused by damaged nerve cells, as forexample nerve cells suffering from post-operative scarring or physicallyimpinged nerve cells commonly associated with degenerative disc disease.Even when nerves function properly, chronic pain sensations areinitiated through nerve cells. Thus, new ways of altering nerve cellfunction, as for example by stabilizing nerve cell wall membranes, maylead to new therapies for the treatment of pain.

[0186] Accordingly, it is an object of the invention to provide a methodfor applying a magnetic field which is particular to this device, to anerve cell such that it alters nerve behavior. This invention relates toa method of applying the magnetic field to the dorsal root ganglia byplacing the device in the epidural space adjacent to the dorsal root. Inthis location, the catheter will modulate or suppress C-fiber firing.Modulation of C-fiber firing will intercept the pain pathway in bothsomatic and sympathetically mediated pain. The helical design of thecatheter allows impingement of the dorsal root regardless of thecatheter's rotation.

[0187] Another object of the invention is to provide a magnetic devicewith a configuration of static magnets with a particular pole designthat, when placed close to a nerve cell, alters the nerve cell'sresponses to external electrical stimuli. In order to achieve the resulton nerve cells, it is necessary that the proximity of the individualmagnets within the device be maintained such that each pole exerts asphere of magnetic influence on the other poles in the device. Anyalteration of the proximity of the magnets one to another, withalternating polarity, will change the effect or cause no effect upon thecell. Any alteration in the balance and symmetry of the power of eachindividual pole with respect to the other three poles will likewiseimpair the effect upon the cell.

[0188] It will be apparent to those skilled in the art that theapparatus of this invention alters C-fiber firing both in vitro and invivo.

[0189] Additional objects and advantages of the present invention willbe set forth in part in the description that follows and, in part, willbe apparent to those skilled in the art from the description or may belearned by practice of the invention.

[0190] G. Cardiac Dysfunction.

[0191] There is taught the methods, devices, techniques, and processeswhich specifically relate to magnetic devices for therapeuticapplication to the human body, and more particularly to a staticpermanent quadripolar treatment device for placement in proximity to thehuman heart to control angina pectoris (“chest pain”) and cardiacdysrhythmia.

[0192] There is further taught the method which provides a device thatalters myocardial behavior in a manner which stabilizes the electricalactivity, dilates myocardial arteries, protects cells from cell deathand controls chest pain which is secondary to ischemia. Another objectof the invention is to provide a magnetic device that alters myocardialbehavior in a manner which controls myocardial ischemia and chest pain.

[0193] There is further taught the method which provides a magneticdevice that alters myocardial behavior by altering sodium and calciumchannel function such that the quadripolar, alternating polarity and thesubsequent field gradient block varying degrees of sodium and calciumchannel function. The degree of blockage is related to the gradient andstrength of the field. The gradient and the field strength may bemanipulated by this technology.

[0194] There is further taught the method which provides an apparatusfor applying a variable magnetic flux to the human body in the area ofthe heart by manipulating components, size and location of theapparatus.

[0195] Application of the present invention relates to magnetic devicesfor therapeutic application to the human body, and more particularly toa static permanent quadripolar treatment device for placement inproximity to the human heart to control angina pectoris (“chest pain”)and cardiac dysrhythmia. The three dimensional flux field gradient, whenapplied to the area of the heart which controls arrhythmia, improvesblood flow, controls angina and protects ischemic myocardial muscle fromcell death.

[0196] Heart disease secondary to coronary disease is a major healthproblem world wide. A common early sign of coronary artery disease iscoronary pain secondary to ischemia. The customary treatment involvesthe use of small vessel dilators such as nitroglycerin, calcium channelblockers and beta adrenergic blockers. These agents have significantside effects associated with their use and many times they do no controlthe pain. This condition is referred to as refractory angina pectoris.The device of this invention is effective in control of refractoryangina pectoris and is actually potentiates the effects of thepharmaceuticals, especially calcium channel blockers.

[0197] Accordingly, it is an object of this invention to provide adevice that alters myocardial behavior in a manner which stabilizes theelectrical activity, dilates myocardial arteries, protects cells fromcell death and controls chest pain which is secondary to ischemia.Another object of the invention is to provide a magnetic device thatalters myocardial behavior in a manner which controls myocardialischemia and chest pain.

[0198] Another object of the invention is to provide a magnetic devicethat alters myocardial behavior by altering sodium and calcium channelfunction such that the quadripolar, alternating polarity and thesubsequent field gradient block varying degrees of sodium and calciumchannel function. The degree of blockage is related to the gradient andstrength of the field. The gradient and the field strength may bemanipulated by this technology.

[0199] It is a further object of the invention to provide an apparatusfor applying a variable magnetic flux to the human body in the area ofthe heart by manipulating components, size and location of theapparatus.

[0200] H. Control of Pain and Sludging of Sickled Cells in Sickle CellDisease.

[0201] There is taught the methods, devices, techniques, and processeswhich relate specifically to control of pain and sludging of sickledcells in sickle cell disease. Particularly a method which implements theinvention to alter cell behavior in a manner that reduces sickle cellsymptoms is taught.

[0202] This invention, when properly placed, provides a device thatalters cell behavior in a manner which blocks or reverses the acutesickling process which leads to low oxygen carrying capacity andsludging of the sickled cells which causes pain and infection of majororgans. The device of the present invention also controls the pain whichis associated with sickling.

[0203] The position of the devices is dictated by the location of thepain in sickle cell crisis. The device may be used prophylactically toprevent sickle cell symptoms.

[0204] The device provides for effective acute relief from sickle cellcrisis and provides for prophylactic use of the devices in someinstances.

[0205] Seizure/Movement Control Applications

[0206] In accordance with the principles of the present invention asembodied and as broadly described herein, a therapeutic static magnetictreatment device-adapted for placement of each device on the head ofliving animals is provided.

[0207] Evidence is presented and provided that the 3 dimensional, steepgradient field created by the invention effectively stops neuronaldischarge in the central nervous system and inhibits or reversescerebral edema.

[0208] I. Seizure Control:

[0209] This application of the present invention relates to magneticdevices for therapeutic application to the human body, and moreparticularly to a quadripolar treatment device for placement on eitherthe outside of the human head or implantable units for control ofseizure disorders.

[0210] Seizure activity in the brain is a rather common occurrence.Clinical seizures result from uncontrolled firing of the brain neurons.This uncontrolled, spontaneous discharge may have projections to manyparts of the brain, causing a variety of clinical presentations. Theseseizures are controlled in many patients by anticonvulsant drugs whichwork through the alteration of ion channels. The drugs increase theseizure threshold by stabilizing neuron cell wall permeability to ionflux. Many of these seizures are not well controlled by medication norany other available modalities. A significant number of these seizuresare resistant to all modalities of treatment. These poorly controlledpatients have a few seizures per month to several per day. Frequent andprolonged seizures cause significant and progressive brain damage.

[0211] Accordingly, it is an object of the invention to provide a devicethat alters brain neuronal behavior in a manner which substantiallystops the abnormal electrical discharge of the neurons, thereforestopping the seizures.

[0212] Another object of the invention is to provide a magnetic devicethat alters brain neuronal behavior in a manner which substantiallystops and controls drug resistant seizures.

[0213] Another object of the invention is to provide a method ofapplying a therapeutic magnetic device to the human head to relieveseizures.

[0214] It is another object of the invention to demonstrate a method ofexternal attachment of the therapeutic quadipolar magnetic device to thearea of the head, a method of implanting the device in the skull tableand a method and apparatus for implanting the device intracerebrally.

[0215] Further taught are methods of implanting the therapeuticquadipolar magnetic device in The skull table or intracerebrally.

[0216] J. Treatment of Movement Disorders.

[0217] The present invention relates to magnetic devices for and methodsfor therapeutic application to the human body, and more particularly toa device for application of the human head in the area of the basalganglia and/or application of a small implantable device to place in theappropriate location in the area of the basal ganglia.

[0218] This invention provides a device (and a method for itsapplications) which is adaptable to be applied to the skin of the heador implanted under stereotactic guidance into areas of the boral gangliafor the control of movement disorders, the device may be used eitheralone or in combination with medication, either to augment or topotentiate the drug effects.

[0219] Movement disorders such as Parkinsonism are treated with drugsand currently an experimental implantable electrical stimulator is beingevaluated. Drugs have a narrow therapeutic window in this particularcomplex of disorders and the electrical stimulator is cumbersome andrequires batteries. There clearly is need for a more simple andeffective technology which has few to no side effects.

[0220] Accordingly, it is an object of the invention to provide a devicewhich is adaptable to be applied to the skin of the head or implantedunder stereotactic guidance into desired areas of the brain for thecontrol of movement disorders, the device may be used either alone or incombination with medication, either to augment or potentiate the drugeffects.

[0221] Accordingly, it is an object of the invention to provide a devicewhich is adaptable to be applied to the skin of the head or implantedunder stereotactic guidance into desired areas of the brain for thecontrol of movement disorders, the device may be used either alone or incombination with medication, either to augment or potentiate the drugeffects.

[0222] Delay of Cell/Tissue Decay Applications

[0223] K. Protection of Transplant Organs.

[0224] There is taught the method which provides a device to bettermaintain cell integrity of transplantable organs by transporting them ina container equipped with a quadripolar magnetic flux generator whichcovers the organ with a step gradient quadripolar static magnetic fluxfield during transport.

[0225] In accordance with the principles of the present invention atherapeutic static magnetic treatment device adapted for placementinside a human organ transplant transport cooler is presented.

[0226] The current invention is designed to better maintain the cellintegrity of the transplantable organ by transporting it in a containerwhich is equipped with a quadripolar magnetic flux generator whichcovers the organ with a steep gradient, quadripolar, static magneticflux field during transport. The field has been shown to possess theability to offer significant protection from cell death.

[0227] This invention further presents the embodiment of the magneticfield in a transport container for such organs as hearts, livers,kidneys, lungs and pancreases.

[0228] Organ transplantation represents the greatest hope in medicinetoday for the effective management of patients in which entire organsystems have failed. Many problems must be dealt with in the successfultransplantation of freshly harvested human organs. A major problem istime from harvesting to transplantation. The donor is frequentlyhundreds of miles and several hours from the recipient. The organs arechilled in saline glucose in an attempt to slow metabolism and retardcatabolism and shock of the organ. The efforts are not totallysuccessful in preserving a good quality organ for transplant. However,due to the shortage of transplantable organs, the less than optimalorgans are usually used.

[0229] There is need for a system which will better maintain theintegrity of the organ such that it is delivered in optimal condition tothe transplant recipient.

[0230] A purpose of the present invention is to better maintain the cellintegrity of the transplantable organ by transporting it in a containerwhich is equipped with a quadripolar magnetic flux generator whichcovers the organ with a step gradient quadripolar static magnetic fluxfield during transport. This field has been shown to possess significantprotection from death for isolated cells and organs in the laboratory.

[0231] L. Protection From Cell Injury and Death Following Neuronal CellInsults Such as Contusion. Hypoxia, Stroke and Infection.

[0232] This application further reveals a method and technique forplacement of the devices on the external body area overlying neuronaltissue such as brain, spinal cord and peripheral nerves following cellinsults such as contusion, hypoxia, stroke, bleeding and infection.

[0233] This application of the present invention relates to magneticdevices for therapeutic application to the human body, and moreparticularly to a quadripolar treatment device for placement on thehuman head, spinal cord or other accessible nervous tissue. to protectinjured or insulted cells from cell death.

[0234] Cerebral ischemia can be either focal or global, employinghypoperfusion of a portion or all the entire brain. Ischemia issecondary to reduction of cerebral blood flow either locally orglobally. Histologically selective neuronal necrosis may occur evenafter brief periods of global ischemia, and after focal ischemia theremay be regions of pan necrosis in the territory of the affected artery.Progressing stroke is an observed deterioration after the initial insultthat can occur for 48 to 96 hours. This phenomenon is likely related toa combination of evolving thrombosis and progressive cell death. Celldeath occurs secondary to hypoxia, spillage of excitatoryneurotransmitters, and spillage of calcium secondary to dying cells inthe region.

[0235] It is the purpose of this invention to present animal data whichdemonstrates protection of brain and other nervous tissue from celldeath in animals who have suffered ischemia or other insults to thenervous tissue. Data will also be presented which demonstratesprotection from brain cell death following direct injection of toxicamino acids into the lateral ventricles.

[0236] A further purpose of this invention are planned clinical trialsfor protection from cell death and the reduction of edema inintracranial hemorrhage, strokes, infections, trauma and spinal cordinjuries.

[0237] M. Magnetic Treatment Device for Treatment of NeurologicalDeficits Including Residual Encephalopathy Following NeurologicalInsults such as Strokes—for Protection from Cell Death and DysfunctionFollowing Hypoxic Injuries

[0238] There is taught the methods, devices, techniques, and processeswhich relate specifically to protection from cell injury and deathfollowing neuronal cell insults such as contusion, hypoxia, stroke andinfection. Also taught is application to the human body, and moreparticularly to a quadripolar treatment device for placement on thehuman dead, spinal cord or other accessible nervous tissue, to protectinjured or insulted cells from cell death.

[0239] This application of the present invention relates to magneticdevices for therapeutic application to the human body and moreparticularly to a magnetic skull cap which utilizes appropriately placedquadripolar devices of the invention for placement on the human head forthe application of several quadrilateral, steep, three dimensionalmagnetic flux field gradient devices.

[0240] This application further reveals a method and technique forplacement of the devices on the external body area of the head using askull cap and spine using a self containing adhesive strip. This willplace the devices over neuronal tissue of the brain and spinal cord.When placed in these positions the devices of the invention will bringabout neuroprotection alone and will augment therapies such as dilantinand other drugs and/or hyperbaric oxygen treatments utilizing variousconcentrations of oxygen and various pressures preferably but notlimited to 100% oxygen and less that 3 atmospheres of pressure forvarying timed intervals and varying number of treatments.

[0241] Cerebral ischemia can be either focal or global, implyinghypoperfusion of the entire brain. Ischemia is secondary to reduction ofcerebral blood flow either locally or globally. Histologically selectiveneuronal necrosis may occur even after brief periods of global ischemia,and after focal iscemia there may be regions of pan necrosis in theterritory of the affected artery. Progressing stroke is an observeddeterioration after the initial insult that can occur for at least 48 to96 hours. This phenomenon is likely related to a combination of evolvingthrombosis and progressive cell death. Cell death occurs secondary tohypoxia, spillage of excitalary neurotransmitters, and spillage ofcalcium secondary to dying cells in the region.

[0242] It is a purpose of this invention to demonstrate neuro protectionof this device both alone and to augment other agents such as drugs andhyperbaric oxygen both in humans and animal modles.

[0243] It is a further purpose of this invention to bring aboutprotection from cell death, reduction of edema and reactivation of livebut poorly functioning neuronal tissue in intra-cranial hemorrhage,strokes, hypoxic ischemicencephalopathy, brain contusions, encephalits,radiation therapy and spinal cord injuries.

[0244] It is a further purpose of this invention to bring aboutprotection from Vasopastic phenomenon secondary to sub arachnoidhemorrhage. The Vasospams results in delayed cerebral ischemia. Theskull cap of the invention generates a magnetic flux field which blocksthe vasospastic phenomenon.

[0245] Diagnostic Applications

[0246] A further object of the invention is to use the combination ofselective skin conductance device for locating underlying pathologyrelated to “pacemaker firing” of underlying excitable tissue with aconfirmation head which contains a high frequency electrical stimulationand a quadripolar alternating magnetic flux generator which suppressesC-fiber firing and activates A-fiber firing in order to give instantconfirmation of the correct location.

[0247] N. MagnaScan™ Device for Locating and Confirming the Placement ofthe Quadripolar Magnetic Device in the Treatment of Pain and OtherDysfunctions.

[0248] A diagnostic apparatus with self-contained therapeuticconfirmation ability for the location of neuropathology in animals isprovided. The device as represented here is designed to be useful forevaluation of local pain such as secondary to local injury and/orinflammation and/or evaluation of radicular pain. The device of theinvention allows one to detect changes in selective tissue conductancein the skin as compared to background. It then allows an electricalstimulation of the receptor field. The stimulus is modulated by aquadripolar magnetic flux generator of the invention such that C-fibersare suppressed and A-fibers are stimulated. When the magnetic fluxgenerator of the invention is placed over the area of maximumconductance in a receptor field which corresponds to the local painpattern, the C-fiber discharge is suppressed. Therefore, pain fiberimpulse is blocked at the area of the dorsal root entry zone. Once thearea of maximum conductance is located, a second head will be rotatedinto place (on a turrent) against the skin. This head, which contains aquadripolar, alternating pole, steep gradient magnetic flux generatorand electrical stimulating means to stimulate electrically andmagnetically. The magnetic gradient suppresses C-fiber firing and theelectrical stimulator activates a-delta, thereby blocking pain entryinto the central nervous system, thereby providing instant confirmationof the correct location.

[0249] An object of this invention to present a method and technique forlocating the proper point for application of the magnetic treatmentdevice in a variety of pain syndromes.

[0250] A further object of this invention is to reveal a diagnosticdevice for locating the area of C-fiber and/or A-fiber dysfunction and amethod for confirming the location by immediate testing of the efficacyby magnetic and electrical stimulation. This invention as represented isdesigned to be useful for evaluation of local pain such as secondary tolocal injury and/or inflammation and/or evaluation of radicular pain.

[0251] There is taught the methods, devices, and techniques which relatespecifically to the Magnascan™ device for locating and confirming theplacement of the quadripolar magnetic device in the treatment of painand other dysfunctions. Further taught is the method which provides fora diagnostic device for locating the area of C-fiber and/or A-fiberdysfunction and a method for confirming the location by immediatetesting of the efficacy by magnetic and electrical stimulation.

[0252] There is further taught the method and technique which providesfor locating the proper point for application of the magnetic treatmentdevice in a variety of pain syndromes.

[0253] There is further taught the method which provides a device whichis useful for evaluation of local pain such as secondary to local injuryand/or inflammation and/or evaluation of radicular pain.

[0254] There is further taught the methods, devices, techniques, andprocesses which relate specifically to local pain and pain in thepattern of referral of nerves that can be treated locally.

[0255] There is further taught the method which provides for a devicewhich when the magnetic flux generator of the invention is placed overthe area of maximum conductance in a receptor field which corresponds tothe local pain pattern, the C-fiber discharge is suppressed.

[0256] There is further taught the method where the pain fiber impulseis blocked distally.

[0257] There is further taught the method wherein the device head willcontain a quadripolar, alternating pole steep gradient magnetic fluxgenerator and wiring means to stimulate electrically and magnetically.

[0258] There is further taught the method wherein the magnetic gradientsuppresses C-fiber firing and the electrical stimulator activatesA-fiber firing in order to give instant confirmation of the correctlocation.

[0259] There is further taught the methods, devices, techniques, andprocesses which relate specifically to radicular pain.

[0260] There is further taught the method wherein when an area ofconductance increases twice background is located, a second head of thedevice will be rotated into place against the skin.

[0261] There is further taught the method wherein the device head willcontain a quadripolar, alternating pole, steep gradient magnetic fluxgenerator and wiring means to stimulate electrically and magneticallythe magnetic gradient suppresses C-fiber firing and the electricalstimulator activates A-firing in order to give instant confirmation ofthe correct location.

[0262] There is further taught the device wherein the magnetic fluxgenerator will suppress C-fiber firing directly and thereby reduce pain.

[0263] There is further taught the device wherein the electricalstimulator will block C-fiber input into the central nervous system inthe area of the substantiation.

[0264] There is further taught the method wherein the technology alsoprovides for plastic containment means.

[0265] 1. Local Pain

[0266] Local pain is generated in the receptor field of the C-fiberswhich conduct painful impulses into the dorsal root entry zone and tohigher centers where the impulse is interpreted as pain. C-fibersympathetic efferent fibers are activated at the cord level and thesefibers innervate the receptor field where the pain originates. TheseC-fiber efferents sensitize the somatic afferents. This sympatheticC-fiber efferent discharge into the receptor field brings about anincrease of electrolyte and therefore increases the tissue conductanceand decreases the resistance. This increased conductance in the skin, ifproperly interpreted, will allow the practitioners to determine the mosteffective locations for the quadipolar magnetic flux generator to beplaced. When the magnetic flux generator of the invention is placed overthe area of maximum conductance in a receptor field which corresponds tothe local pain pattern, the C-fiber discharge is suppressed. Therefore,pain fiber impulse is blocked distally. According to the presentinvention, once the area of maximum conductance is located, a secondhead will be rotated into place against the skin. This head will containa quadripolar, alternating pole steep gradient magnetic flux generatorand wiring means to stimulate electrically and magnetically. Themagnetic gradient suppresses C-fiber firing and the electricalstimulator activates A-fiber firing in order to give instantconfirmation of the correct location.

[0267] 2. Radicular Pain

[0268] Radicular pain is generated by abnormal C-fiber discharge withinthe dorsal root. The symptoms are many such as compression,inflammation, hypoxia, contusion, and neuroproxia.

[0269] The dorsal division of the dorsal root is a small remnant inhumans and only innervates a narrow strip of tissue on either side ofthe spinal cord. This dorsal division of the dorsal root containssympathetic efferent fibers in addition to somatic afferents. Theseefferent fibers discharge into the receptor field, thereby increasingskin conductance. Therefore, in this instance areas of increasedconductance of the skin superficial to the root are compatible withcompression, radiculitis or other malfunction of the dorsal root.According to the invention, when an area of conductance increases twicebackground is located, a second head of the device will be rotated intoplace against the skin. This head will contain a quadripolar,alternating pole, steep gradient magnetic flux generator and wiringmeans to stimulate electrically and magnetically the magnetic gradientsuppresses C-fiber firing and the electrical stimulator activatesA-firing in order to give instant confirmation of the correct location(See Fig. Gate Control Theory). The magnetic flux generator willsuppress C-fiber firing directly and thereby reduce pain. The electricalstimulator will block C-fiber input into the central nervous system inthe area of the substantiation.

[0270] Another object of this invention is to present an electricalstimulator comprised of a pulse generator, controls for controlling thepulse frequency and morphology and an annular electrode system for bothconductance reading and a second hear with an annular electrode forstimulation. The technology also provides for plastic containment means.

[0271] O. Potentiation of Pharmaceuticals and Focusing the Point ofMaximum Therapy by Concentrating Drug to the Active Site.

[0272] The present invention relates to magnetic devices for therapeuticapplication to the human body, and more particularly to various sizedmagnetic devices for placement on the area of the human body in whichdrug potentiation is desired, such that the steep field gradientquadripolar field will interact with the drug, receptor or both.

[0273] There is taught the methods, devices, techniques, and processeswhich relate specifically to potentiation of pharmaceuticals andfocusing the point of maximum therapy by concentrating drug to theactive site.

[0274] There is further taught the methods, devices, techniques, andprocesses which relate specifically to magnetic devices for therapeuticapplication to the human body particularly to various sized magneticdevices for placement on the area of the human body in which drugpotentiation is desired, such that the steep field gradient quadripolarfield will interact with the drug and/or receptor.

[0275] There is further taught the methods which provides for potentiatethe therapeutic effects at the receptor site.

[0276] There is further taught the methods which provides for use ofmagnetically compliant drugs which are thereby concentrated at thereceptor area.

[0277] There is further taught the methods which potentiate the onsetand intensity and duration of local anesthetics such as lidocaine whenused as a dermally applied gel underneath the magnetic device for thepurpose of bringing about rapid local anesthesia for minor procedures.

[0278] There is further taught the methods which place an intracranialquadripolar micro implant near an irritable focus to potentiate theeffects of dilantin in the control of seizures which are drug resistant.

[0279] The use of pharmaceutical agents in medicine is at an all timehigh. Along with the desired effects, many drugs have significant sideeffects (undesirable effects) at the doses needed for the desiredtherapeutic effects. It is an object of this invention to potentiate thetherapeutic effects at the receptor site, and in some instances in whichmagnetically compliant drugs are involved, the technology of thisinvention will concentrate the drug at the receptor area.

[0280] It is a further object of this invention to potentiate the onsetand intensity and duration of local anesthetics such as lidocaine whenused as a dermally applied gel underneath the magnetic device for thepurpose of bringing about rapid local anesthesia for minor procedures.

[0281] It is a further object of this invention to place an intracranialquadripolar micro implant near an irritable focus to potentiate theeffects of dilantin in the control of seizures which are drug resistant.

[0282] Other Applications

[0283] P. Magnetic Placebo.

[0284] There is taught the method which provides a magnetic placebo foruse in clinical trials. Further taught is a device which provides nobiological ability yet is magnetic and has all of the appearance andphysical characteristics of the authentic device except there are noalternating poles and it has no significant field gradient.

[0285] A therapeutic, static magnetic treatment placebo for placementagainst the bodies of living animals is provided in which each of threethe poles is made of non-magnetizable aluminum. The fourth pole is madeof a weak magnetized neodymium magnet with the negative pole facing thebody of the animal. In addition, this invention provides a flux blockingplate made of 26 gauge galvanized steel. The plate is square and islocated between the poles and the skin.

[0286] This application further reveals a method and technique forplacement of the devices on the external body in an area of the body inplace of an authentic device in a double blinded fashion.

[0287] It is a further purpose of this invention to present a magneticplacebo for use in clinical trials. The magnetic placebo has nobiological ability yet it is magnetic and has all of appearance andphysical characteristics of the authentic device except the alternatingpoles and it has no significant field gradient.

[0288] Another object of this invention is to present a magnetictreatment placebo which is designed to have minimal field gradient andall positive poles facing the animal body. This object is accomplishedby forming a quadripolar array as in the authentic device. Three of thepoles are non-magnetizable aluminum and the fourth pole is a magneticpole which is about one half the strength of therapeutic poles of theauthentic therapeutically active device. A square flux blocking platemade of galvanized steel is placed between the poles and the animal skinsuch that a weaker, diffuse magnetic flux field of all negative magneticflux facing the animal skin.

[0289] Q. Control of Nausea and Vomiting Associated with PregnancyMotion and Chemotherapy.

[0290] This application reveals a method and technique for placement ofthe invention on the external body area over the vestibules apparatusand the distal medial radius area for the control of nausea and vomitingassociated with pregnancy, motion and chemotherapy.

[0291] There is further taught the methods, devices, techniques, andprocesses which specifically relates to nausea and vomiting associatedwith pregnancy, motion and chemotherapy and also secondary to a varietyof external stimuli.

[0292] The present invention relates to magnetic devices for therapeuticapplication to the human body and more particularly to a static magneticquadripolar treatment device for placement on the human body for controlof nausea and/or vomiting associated with pregnancy, motion sickness andchemotherapy.

[0293] Nausea and vomiting associated with a variety of stimuli iscontrolled by the emetic center in the central nervous system. Thistechnology of the present invention controls the nausea and vomitingsecondary to a variety of underlying etiologies by modulating peripheralinput into the CNS. This is accomplished by placing the device justproximal and lateral to the wrist on the palmar surface of both armsand/or placement over the vestibular apparatus (posterior to theexternal ear).

[0294] R. Prevention of Fertilization of the Ovum by the Sperm.

[0295] This application further reveals a method and technique forplacement of the invention as part of a safe and effective intra-uterinedevice to prevent fertilization of the ovum by the sperm. The devicewill contain 6 quadripolar devices in a containment means to hold thedevice in a stable condition such that the entire uterus will respond tothe flux and thereby prevent penetration of the ovum by the sperm.

[0296] It is a further object of the invention to provide a device thatblocks the fertilization of the ovum by human or animal sperm.

[0297] Another object of the invention is to provide an apparatus forapplying a symmetric quadripolar, three dimensional magnetic flux fieldwhich is focused and balanced to the human body to block penetration ofthe ovum by the sperm.

[0298] It is a further object of the invention to demonstrate that theprimary mechanism is through calcium channel blockade.

[0299] A further object of the invention to provide a method forapplying a therapeutic magnetic device to the human body to controlfertilization of the human ovum by a sperm.

[0300] The foregoing embodiments are presented by way of example only;the scope of the present invention is to be limited only by thefollowing claims.

1. A method for altering the charge distribution upon living membraneswith functional stabilizational of the membrane physical electricalintegrity.
 2. A method for altering the charge distribution upon livingmembranes with functional stabilizational of the membrane physicalelectrical integrity for applying a symmetric, and balanced to the humanbody to stabilize excitable membranes and thereby reduce pain associatedwith the spontaneous pacemaker firing of chronically malfuctioningpolymodal nociceptors (afferent C-fibers and A delta fibers).
 3. Anapparatus for altering the charge distribution upon living membraneswith functional stabilizational of the membrane physical electricalintegrity further comprising a method for using submicroscopic,quadripolar, circular, center charged, energy balanced magnetic devicein a four (4) magnet array of alternating polarity in which the magneticpoles are separated only by a distance which will allow a magneticsphere of influence on all adjacent poles to suppress the firing ofaction potentials of mammalian sensory neurons.
 4. The method andapparatus in claims 1, 2 or 3, wherein the apparatus provides a staticmagnetic device for production of a magnetic field for treatment ofvarious disorders.
 5. The apparatus of claim 3, further providing astatic magnetic device for production of a magnetic field for treatmentof disorders wherein the device provides a static magnetic pole of likepolarity on the outer surface of the flux focusing ring adjacent to eachof the 4 poles of the invention (focusing magnet) such that the end rtop of the focusing magnet is oriented to the geometric side of the polesuch that the asix of the two magnets form a 45 to 90 degree angle. 6.The apparatus of claim 3, wherein further comprising implantable,quadripolar devices which contain flux focusing and flux return rings.7. The apparatus in claim 3, wherein the apparatus is utilized to treatand transport human organs for donation.
 8. The apparatus in claim 3,wherein the method and apparatus counteracts the negative effects ofpain and swelling while promoting wound healing.
 9. The apparatus ofclaim 3, further providing an apparatus for applying a symmetricquadripolar, three dimensional magnetic flux field which is focused andbalanced to the human body to stabilize excitable membranes and therebyreduce pain and edema associated with acute injury, inflammation orsurgical procedure and to decrease wound healing time.
 10. The apparatusin claim 3, further providing an alternating, quadripolar array in whicheach of the poles is in the shape of two cones joined at the directrixof the cone with the vertex of the two cones lying in a perpendicularaxis of a circular directrix.
 11. The apparatus in claim 3, wherein theapparatus further provides a flux focusing ring surrounding the 4 staticmagnetic poles on the outer perimeter stationed essentially midwaybetween the top and bottom of the pole.
 12. The method and apparatus inclaims 1, or 2 or 3, further providing means for counteracting thenegative effects of chronic pain while promoting wound healing.
 13. Amethod for altering the charge distribution upon living membranes withfunctional stabilizational of the membrane physical electrical integrityfor applying a symmetric, and balanced magnetic field to the livingmembranes to stabilize excitable membranes and thereby reduce painassociated with the spontaneous pacemaker firing of chronicallymalfunctioning polymodal nociceptors (afferent C-fibers and A deltafibers).
 14. An apparatus for altering the charge distribution uponliving membranes with functional stabilizational of the membranes'physical electrical integrity, the apparatus comprising: (a) asubmicroscopic, quadripolar, circular, center charged, energy balancedmagnetic device in a four (4) magnet array of alternating polarity inwhich magnetic poles are separated only by a distance which will allow amagnetic sphere of influence on all adjacent poles to suppress thefiring of action potentials of mammalian sensory neurons; (b) a fluxfocusing ring surrounding the 4 magnet array on the outer perimeterstationed essentially midway between the top and bottom of the magneticpoles; and (c) a flux return ring away from the membrane surface forreturning the magnetic flux thereby altering the strength and gradientwithout altering center charge symmetry and homogeneity of the3-dimensional steep gradient field with is in contact with the membrane.15. The apparatus in claim 14, wherein the apparatus provides a staticmagnetic device for production of a magnetic field for treatment ofvarious disorders.
 16. The apparatus of claim 14, further providing astatic magnetic device for production of a magnetic field for treatmentof disorders wherein the device provides a static magnetic pole of likepolarity on the outer surface of the flux focusing ring adjacent to eachof the 4 poles of the magnets such that the focusing magnet is orientedto the geometric side of the pole such that the axis of two magnets forma 45 to 90 degree angle.
 17. The apparatus of claim 14, furthercomprising implantable, quadripolar devices which contain flux focusingand flux return rings.
 18. The apparatus in claim 14, wherein theapparatus is utilized to treat and transport human organs for donation.19. The apparatus in claim 14, wherein the apparatus counteracts thenegative effects of pain and swelling while promoting wound healing. 20.The method of claim 13, further providing the step of applying asymmetric quadripolar, three dimensional magnetic flux field which isfocused and balanced to the human body to stabilize excitable membranesand thereby reduce pain and edema associated with acute injury,inflammation or surgical procedure and to decrease wound healing time.21. The apparatus in claim 14, further providing an alternating,quadripolar array in which each of the poles is in the shape of twocones joined at the directrix of the cone with the vertex of the twocones lying in a perpendicular axis of a circular directrix.
 22. Theapparatus claim 14, further providing means for counteracting thenegative effects of chronic pain while promoting wound healing.